Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT02804958
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute STEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1537}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACCE', 'timeFrame': 'Within the 1 year', 'description': 'Major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction and non-fatal stroke'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': 'Within the 1 year'}, {'measure': 'Non-fatal myocardial infarction', 'timeFrame': 'Within the 1 year'}, {'measure': 'Non-fatal stroke', 'timeFrame': 'Within the 1 year'}, {'measure': 'Ischemic-driven revascularization', 'timeFrame': 'Within the 1 year'}, {'measure': 'Admission for heart failure', 'timeFrame': 'Within the 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ST-segment elevation myocardial infarction', 'Primary percutaneous coronary intervention', 'Clinical outcomes'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.', 'detailedDescription': 'INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.\n\nDemographic data, cardiovascular risk factors, laboratory data and clinical follow-up data were collected. Baseline blood test was obtained and recorded as part of the routine care for patients who visited the emergency room for chest pain and in whom acute coronary syndrome was suspected. Standard medical management was provided by responsible physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) were consecutively registered. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with acute ST-segment elevation myocardial infarction\n* Patients treated with primary percutaneous coronary intervention\n\nExclusion Criteria:\n\n* Patients diagnosed with Non-ST-segment elevation acute coronary syndrome\n* Patients treated with thrombolytic therapy'}, 'identificationModule': {'nctId': 'NCT02804958', 'briefTitle': 'Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute STEMI', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Incheon-Bucheon Cohort of Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'INTERSTELLAR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEMI treated with primary PCI', 'description': 'Patients diagnosed with acute ST-segment elevation myocardial infarction and treated with primary percutaneous coronary intervention were consecutively registered.', 'interventionNames': ['Procedure: STEMI treated with primary PCI']}], 'interventions': [{'name': 'STEMI treated with primary PCI', 'type': 'PROCEDURE', 'description': 'Primary percutaneous coronary intervention was performed according to the current standard guidelines. Coronary angiography was performed using standard techniques. The use of thrombectomy devices, intravascular ultrasound, intra-aortic balloon pump, and percutaneous cardiopulmonary support was up to the operator.', 'armGroupLabels': ['STEMI treated with primary PCI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Sejong General Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Woong Chol Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Soon Chun Hyang University', 'class': 'OTHER'}, {'name': 'Sejong General Hospital', 'class': 'OTHER'}, {'name': 'Inha University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woong Chol Kang', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}